| Trial ID: | L3424 |
| Source ID: | NCT04956263
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| Associated Drug: |
Yg1699
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| Title: |
A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Type1diabetes|Diabetes Mellitus
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| Interventions: |
DRUG: YG1699|DRUG: Dapagliflozin
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| Outcome Measures: |
Primary: Concentration-time curve in plasma glucose (AUC(0-120min) ), To demonstrate that either dose of YG1699 produces a lower area under the concentration-time curve in plasma glucose (AUC(0-120min) ) \[mg/dL\*ml\] expressed as percent of No Treatment mean versus Dapagliflozin after a standardized Mixed Meal Tolerance Test (MMTT), performed on the 6th day of treatment., 6th day of treatment | Secondary: Objectives for MMTT, * To evaluate the change from the No Treatment Period versus the Active Treatment Periods in plasma glucose after the MMTT, performed on the 6th day of treatment, at 2-hour postprandial (120 minutes) of YG1699 doses versus Dapagliflozin (This endpoint may become primary endpoint after interim analysis) * To evaluate the change from the No Treatment Period versus the Active Treatment Periods in urinary glucose excretion (UGE) after the MMTT on the 6th day of treatment, (UGE 0-180 minutes) of YG1699 doses versus Dapagliflozin * To evaluate the change from the No Treatment Period versus the Active Treatment Periods in plasma glucose after the MMTT, performed on the 6th day of treatment, during 3-hour postprandial (180 minutes) at individual time points, and maximum plasma glucose of YG1699 doses versus Dapagliflozin, 6th day of treatment|Objectives for Insulin Withdrawal, • To evaluate the increment and ratio of changes from the No Treatment Period versus the Active Treatment Periods during insulin withdrawal performed on the 7th day of treatment, in: * Treatment Ratios (95% CI) of the following: Serum beta-hydroxybutyrate (BOHB) , plasma glucagon , plasma glucose , plasma free fatty acids (FFA) * Duration of insulin withdrawal, 7th day of treatment|Objectives for Insulin Requirements, To evaluate the change from the No Treatment Period versus the Active Treatment Periods in basal, bolus and total daily insulin dose requirements, over 3 days prior to the MMTT
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| Sponsor/Collaborators: |
Sponsor: Youngene Therapeutics Inc., Ltd. | Collaborators: ProSciento, Inc.
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE2
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| Enrollment: |
19
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2021-06-17
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| Completion Date: |
2022-07-19
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| Results First Posted: |
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| Last Update Posted: |
2022-07-28
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| Locations: |
ProSciento, Inc, Chula Vista, California, 91911, United States
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| URL: |
https://clinicaltrials.gov/show/NCT04956263
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